RAC Premarketing and Clinical Development 2

Question 1

Which IND type allows a sponsor to ship an investigational drug to clinical investigators without a 30-day FDA review period?

Accepted Answer

Emergency IND

Answer

An Emergency IND allows FDA to authorize use over the phone before submission, bypassing the standard 30-day waiting period.

Question 2

In a Phase I dose-escalation oncology trial, what is the primary endpoint typically used to determine the Maximum Tolerated Dose (MTD)?

Accepted Answer

Dose-Limiting Toxicity (DLT)

Answer

DLTs observed during the first treatment cycle define the MTD boundary in classic 3+3 and modified dose-escalation designs.

Question 3

Under 21 CFR Part 312, which section requires sponsors to report unexpected serious adverse events from foreign clinical studies to the IND within 15 calendar days?

Accepted Answer

312.32

Answer

21 CFR 312.32 governs IND safety reporting, requiring 15-day expedited reports for unexpected serious adverse drug reactions from any source.

Question 4

A sponsor wants to conduct a single-dose PK study in six healthy volunteers using a microdose (≤100 mcg) to characterize absorption without triggering full IND requirements. Which IND category applies?

Accepted Answer

Exploratory IND

Answer

Exploratory INDs (Phase 0) permit very limited human exposure with microdoses primarily to obtain early pharmacokinetic or pharmacodynamic data.

Question 5

What is the purpose of a Special Protocol Assessment (SPA) agreement between a sponsor and FDA for a Phase III trial?

Accepted Answer

To secure FDA agreement that the protocol design is acceptable to support a future NDA/BLA

Answer

An SPA provides sponsors with FDA's binding agreement that the protocol design, endpoints, and statistical analysis plan are acceptable for regulatory approval.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Premarketing and Clinical Development 2